Linaclotide for Chronic Constipation in Type 2 Diabetes

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Texas Tech University Health Sciences Center, El Paso

Must not be taking: Prokinetics, Opiates, Anti-spasmodics, NSAIDs

Disqualifiers: Pregnancy, Severe gastroparesis, Diverticulitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side effects are going to be assessed at each appointment. Patients are going to be assigned by the computer, to receive an active or non-active drug for 14 days in a first phase. The order will be change during the second phase. The 2 weeks break without our medication will separate these phases. A very close observation regarding safety of our subjects will be implemented by study personnel and clinical investigators.

Who Is on the Research Team?

Irene Sarosiek, MD

Principal Investigator

Texas Tech University Health Sciences Center- El Paso, Texas

Are You a Good Fit for This Trial?

This trial is for Type II diabetics who've had chronic constipation for at least 6 months, with hard or lumpy stools. They should have less than three spontaneous bowel movements per week and not be using laxatives frequently. People with severe diseases, high hemoglobin A1c levels (>8.2), drug/alcohol abuse, certain gastrointestinal surgeries, or severe hemorrhoids can't join.

Inclusion Criteria

I have type II diabetes.

I have been constipated for at least 6 months.

I have had constipation for over 6 months with hard stools and often feel incomplete after going.

Exclusion Criteria

I regularly take NSAIDs more than three times a week.

I do not have any severe illnesses that my doctor thinks should keep me out of the study.

I haven't used laxatives (except fiber) 3 days before joining, and won't use them often during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either linaclotide or placebo for 14 days

2 weeks

2 visits (in-person)

Washout

A 2-week break without medication to separate treatment phases

2 weeks

Treatment Phase 2

Participants receive the alternate treatment (linaclotide or placebo) for 14 days

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Linaclotide

Trial Overview The study tests Linaclotide against a placebo in people with diabetes and chronic constipation over two phases of 14 days each, separated by a two-week break. Participants are randomly assigned to start with either the active drug or placebo and then switch after the break.

How Is the Trial Designed?

Group I: 1)28days of linaclotide or placebo Active Control 1 Intervention

patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.

Group II: 2)28days of linaclotide or placebo Active Control 1 Intervention

patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.

Linaclotide is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Linzess for:

• Chronic idiopathic constipation
• Irritable bowel syndrome with constipation (IBS-C)
• Functional constipation in pediatric patients 6 to 17 years of age

Approved in European Union as Constella for:

• Chronic idiopathic constipation
• Irritable bowel syndrome with constipation (IBS-C)

Approved in Canada as Linzess for:

• Chronic idiopathic constipation
• Irritable bowel syndrome with constipation (IBS-C)
• Functional constipation in pediatric patients 6 to 17 years of age

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center, El Paso

Lead Sponsor

Trials

51

Recruited

5,800+